HYDROPULSE
Contribution of Cerebral Pulsatility Assessment by Transcranial Ultrasound to the Decision-making for Cerebrospinal Fluid Shunting in Patients With Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
Sponsor study identifier
observational
110
1 country
1
Study Start
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization in the neurosurgery department, followed by a second ultrasound assessment either at one year after surgery for operated patients, or at one year after the initial ultrasound assessment for non-operated patients. This ultrasound evaluation will be integrated into the routine work-up, which is already systematically performed in cases of suspected idiopathic normal pressure hydrocephalus (iNPH). The neurosurgical team's decision to perform cerebrospinal fluid (CSF) shunting will be made blinded to the ultrasound measurements and based solely on the standard clinical protocol. The primary objective of the study is to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) prior to subtractive lumbar puncture is significantly higher in patients who show clinical improvement 12 months after CSF shunting compared with those who do not, with a type I error risk (alpha) of 0.05."
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 17, 2025
Actual (reported)December 16, 2025
Actual (reported)May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Clinical improvement
Clinical improvement at 12 months in patients who undergo CSF shunt surgery (ventriculoperitoneal shunt, VPS). Clinical improvement will be defined as cognitive improvement at 12 months and/or gait improvement at 12 months. * Cognitive improvement: improvement in at least two cognitive tests. Improvement in a single test will be defined as an increase ≥ 1 standard deviation between the baseline pre-lumbar puncture (pre-LP) speech therapy evaluation and the 12-month postoperative assessment. * Gait improvement: improvement in the Get Up and Go test and/or the 10-meter walk test (10MWT) between baseline and the 12-month postoperative assessment.
12 months
Mattis Dementia Rating Scale score (MDRS)
12 months
Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)
12 months
Get Up and Go test (s)
12 months
10-meter walk test
12 months
Reduction in modified Rankin Scale score (≤ 1 point compared with baseline) at 12 months
12 months
Adult with suspected iNPH, hospitalized at Tours University Hospital for "hydrocephalus assessment"
university hospital, Tours
Tours, 37044, France
Ternifi R, Cazals X, Desmidt T, Andersson F, Camus V, Cottier JP, Patat F, Remenieras JP. Ultrasound measurements of brain tissue pulsatility correlate with the volume of MRI white-matter hyperintensity. J Cereb Blood Flow Metab. 2014 Jun;34(6):942-4. doi: 10.1038/jcbfm.2014.58. Epub 2014 Apr 9.
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Ilyess ZEMMOURA, Pr
University Hospital, Tours
First Submitted
November 17, 2025
First Posted
December 16, 2025
Study Start
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2028
EstimatedContact the study team to confirm eligibility.
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Miyajima M, Kazui H, Mori E, Ishikawa M; , on behalf of the SINPHONI-2 Investigators. One-year outcome in patients with idiopathic normal-pressure hydrocephalus: comparison of lumboperitoneal shunt to ventriculoperitoneal shunt. J Neurosurg. 2016 Dec;125(6):1483-1492. doi: 10.3171/2015.10.JNS151894. Epub 2016 Feb 12.
Carlsen JF, Munch TN, Hansen AE, Hasselbalch SG, Rykkje AM. Can preoperative brain imaging features predict shunt response in idiopathic normal pressure hydrocephalus? A PRISMA review. Neuroradiology. 2022 Nov;64(11):2119-2133. doi: 10.1007/s00234-022-03021-9. Epub 2022 Jul 24.
Nakajima M, Yamada S, Miyajima M, Ishii K, Kuriyama N, Kazui H, Kanemoto H, Suehiro T, Yoshiyama K, Kameda M, Kajimoto Y, Mase M, Murai H, Kita D, Kimura T, Samejima N, Tokuda T, Kaijima M, Akiba C, Kawamura K, Atsuchi M, Hirata Y, Matsumae M, Sasaki M, Yamashita F, Aoki S, Irie R, Miyake H, Kato T, Mori E, Ishikawa M, Date I, Arai H; research committee of idiopathic normal pressure hydrocephalus. Guidelines for Management of Idiopathic Normal Pressure Hydrocephalus (Third Edition): Endorsed by the Japanese Society of Normal Pressure Hydrocephalus. Neurol Med Chir (Tokyo). 2021 Feb 15;61(2):63-97. doi: 10.2176/nmc.st.2020-0292. Epub 2021 Jan 15.
Mori E, Ishikawa M, Kato T, Kazui H, Miyake H, Miyajima M, Nakajima M, Hashimoto M, Kuriyama N, Tokuda T, Ishii K, Kaijima M, Hirata Y, Saito M, Arai H; Japanese Society of Normal Pressure Hydrocephalus. Guidelines for management of idiopathic normal pressure hydrocephalus: second edition. Neurol Med Chir (Tokyo). 2012;52(11):775-809. doi: 10.2176/nmc.52.775.
Ishikawa M, Hashimoto M, Kuwana N, Mori E, Miyake H, Wachi A, Takeuchi T, Kazui H, Koyama H. Guidelines for management of idiopathic normal pressure hydrocephalus. Neurol Med Chir (Tokyo). 2008;48 Suppl:S1-23. doi: 10.2176/nmc.48.s1.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 30, 2026
Record last verified: 2026-04
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